Healthy VolunteerPhase 1NCT01309425
A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers
A Phase 1 study testing tapentadol (CG5503) ER two 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF and tapentadol (CG5503) ER 25-mg TRF in people with Healthy Volunteer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- tapentadol (CG5503) ER two 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF and tapentadol (CG5503) ER 25-mg TRF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese and Korean male volunteers, inclusive
- Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg
- Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and paternal grandparents are Japanese.
- Korean volunteers must have resided outside of Korea for no more than 5 years and their parents and maternal and paternal grandparents are Korean.
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease
- History of hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities
- History of significant pulmonary disease, including bronchospastic respiratory disease
- History of diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol-acetaminophen, within 14 days before the first dose of the study drug is scheduled
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
About this study
Official title: A Single-Dose, Open-Label, Randomized, Four-Way Crossover Study to Assess the Dose-Proportionality of the Pharmacokinetics of Tapentadol, Given as Tamper-Resistant Tablets, in Healthy Japanese and Korean Male Subjects
The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.
Read the detailed description
This is a single-dose, open-label, single-center, randomized, four-way crossover study, ie, participants and investigator know the identity of the drug, which is assigned by chance, like flipping a coin, and participants may receive different interventions sequentially during the study. The study will consist of 4 treatment periods. A single dose of tapentadol (CG5503) will be administered orally with 240 mL of water under fasted conditions. All participants will receive 1 of the following 4 oral treatments in each period.
Treatment A: One 25-mg tablet (25 mg) of tapentadol (CG5503) Treatment B: One 50-mg tablet (50 mg) of tapentadol (CG5503) Treatment C: One 100-mg tablet (100 mg) of tapentadol (CG5503) Treatment D: Two 100-mg tablets (200 mg) of tapentadol (CG5503) Each period will be separated by 7 - 14 days.
- Conditions
- Healthy Volunteer
- Being tested
- tapentadol (CG5503) ER two 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF, tapentadol (CG5503) ER 25-mg TRF, tapentadol (CG5503) ER 100-mg TRF
- Keywords
- tapentadol, NUCYNTA, CG5503, R331333, pharmacokinetics, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tapentadol (CG5503) ER two 100-mg TRFDrug
200mg TRF single oral dose
tapentadol (CG5503) ER 50-mg TRFDrug
50mg TRF single oral dose
tapentadol (CG5503) ER 25-mg TRFDrug
25mg TRF single oral dose
tapentadol (CG5503) ER 100-mg TRFDrug
100mg TRF single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose Receives: Drug: tapentadol (CG5503) ER 25-mg TRF |
| 002 | Experimental | tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose Receives: Drug: tapentadol (CG5503) ER 50-mg TRF |
| 003 | Experimental | tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose Receives: Drug: tapentadol (CG5503) ER 100-mg TRF |
| 004 | Experimental | tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose Receives: Drug: tapentadol (CG5503) ER two 100-mg TRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2
Measured: Two days
Secondary outcomes (1)
Number of participants with adverse events
Measured: Time of screening to end of treatment (up to 9.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309425
- Sponsor's protocol ID
- CR017782
- Other IDs
- R331333PAI1064
- Status last verified
- Oct 2012
- First submitted
- 3 Mar 2011
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Four-Way Crossover Study to Assess the Dose-Proportionality of the Pharmacokinetics of Tapentadol, Given as Tamper-Resistant Tablets, in Healthy Japanese and Korean Male Subjects
- ClinicalTrials.gov ID
- NCT01309425
- Acronym / sponsor ID
- CR017782
- Conditions
- Healthy Volunteer
- Keywords
- tapentadol, NUCYNTA, CG5503, R331333, pharmacokinetics, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Study completion
- May 2011 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.
Detailed description
This is a single-dose, open-label, single-center, randomized, four-way crossover study, ie, participants and investigator know the identity of the drug, which is assigned by chance, like flipping a coin, and participants may receive different interventions sequentially during the study. The study will consist of 4 treatment periods. A single dose of tapentadol (CG5503) will be administered orally with 240 mL of water under fasted conditions. All participants will receive 1 of the following 4 oral treatments in each period.
Treatment A: One 25-mg tablet (25 mg) of tapentadol (CG5503) Treatment B: One 50-mg tablet (50 mg) of tapentadol (CG5503) Treatment C: One 100-mg tablet (100 mg) of tapentadol (CG5503) Treatment D: Two 100-mg tablets (200 mg) of tapentadol (CG5503) Each period will be separated by 7 - 14 days.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: tapentadol (CG5503) ER 25-mg TRFtapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose |
| 002 | Experimental | Drug: tapentadol (CG5503) ER 50-mg TRFtapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose |
| 003 | Experimental | Drug: tapentadol (CG5503) ER 100-mg TRFtapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose |
| 004 | Experimental | Drug: tapentadol (CG5503) ER two 100-mg TRFtapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Japanese and Korean male volunteers, inclusive
- Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg
- Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and paternal grandparents are Japanese.
- Korean volunteers must have resided outside of Korea for no more than 5 years and their parents and maternal and paternal grandparents are Korean.
Key exclusion criteria (6 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease
- History of hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities
- History of significant pulmonary disease, including bronchospastic respiratory disease
- History of diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol-acetaminophen, within 14 days before the first dose of the study drug is scheduled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tapentadol (CG5503) ER two 100-mg TRF200mg TRF single oral dose | Drug | 004 |
| tapentadol (CG5503) ER 50-mg TRF50mg TRF single oral dose | Drug | 002 |
| tapentadol (CG5503) ER 25-mg TRF25mg TRF single oral dose | Drug | 001 |
| tapentadol (CG5503) ER 100-mg TRF100mg TRF single oral dose | Drug | 003 |
Primary outcome
Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2
Time frame: Two days
1 secondary outcome
Number of participants with adverse events
Time frame: Time of screening to end of treatment (up to 9.5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tapentadol (CG5503) ER two 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF and tapentadol (CG5503) ER 25-mg TRF in people with Healthy Volunteer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2 (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.